Increasing and complex regulatory requirements, Globalization of Pharmacovigilance, Public and Politic expectations: The new proactive approach of Risk Management


If you want to ensure the safety of your products and the compliance to regulation you need:

  • A high level of expertise
  • A medical and a pharmacological analysis
  • Organizational skills
  • Communication talents
  • A range of technical solutions
  • A Rigorous Quality Assurance securing your processes

ADDS has all the expertise and capacities to provide:

  • Whole outsourcing of the Pharmacovigilance System including the European Qualified Person for Pharmacovigilance EUQPPV
  • Operational support
  • Consultancy
  • All along the product lifecycle :
    • from early Clinical Trials
    • to Post-marketing settings
    • through Marketing Approval dossier period

Partners and networks:

Worldwide network

US and EU Regulation Intelligence Lobbying

  • ADDS Affiliates
    • France, Czech Republic, North Africa, Israel
  • Partners in Safety
    • BIOSOTERIA USA
    • MAKROCARE INDIA
    • BIOFORUM ISRAEL
  • Network Experts
    • EUQPPV Organization, ISOP, AFCRO, AMIPS, IFIS, DIA.
  • Collaboration with Health Authoritie

Know-how:

PV team of Senior professionals with a broad experience in Pharmacovigilance and certification to Eudravigilance

Expertise in

  • Immunology-Hematology
  • Biotechnology
  • Advanced Therapies
  • Medical Device
  • Oncology
  • Pharmacology - Pharmacokinetics
  • Neurology
  • Internal medicine

Experience as

  • EUQPPVs
  • Pharmacist Manager
  • Regulatory Affairs Director
  • National PV Supervisors
  • Medical Affairs Director
  • CRA Manager

Operational Staff

With a dedication to

  • Safety data management
  • Data base administration
  • Eudravigilance and electronic reporting
  • 1rst level of answer to medical information
  • Quality check
  • Compliance
  • Handling of PV System Master File
  • Q&A data base management